Patients with ESRD treated by CAPD MedDRA version: 9.1 Level: PT Classification code 10038444
Conditions
Interventions
Product Name: Peritoneal Dialysis Solution - L-carnitine 0,02 %
Xylitol 1,5%
glucose 0,5 % for nocturnal dwell
Product Code: IPX15
Pharmaceutical Form: Solution for peritoneal dialysis
Current Sponsor code: IPX15
Concentration unit: % percent
Concentration type: equal
Product
Sponsors
IPERBOREAL PHARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study, patients of both genders must fulfill the following criteria, verified during the screening period: 1. Age =18 years; 2. Diagnosis of ESRD treated for at least three month with CAPD, as stated by the medical staff of the center; 3. Stable clinical condition within four weeks before screening period, certified by medical/surgical history, physical examination and laboratory exploration; 4. Hemoglobin level =9g/dL; 5. Absence of acute peritonitis and/or peritoneal catheter infection (either exit site or subcutaneous tunnel) episodes within three months before selection; 6. To understand and sign an informed consent form. For patients who will be included in Group B, the following criteria must be fulfilled too: 7. Be treated with Extraneal (nocturnal exchange bag solution) for at least 1 month 8. Be treated with 1; 2 or 3 diurnal exchange bag solutions (solution bags with 1,5% glucose) and one nocturnal exchange bag solution with icodextrin (Extraneal). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who fulfill one or more of the following criteria will not be enrolled in the study: 1. History of alcohol or drug abuse in the last six months before selection for the study; 2. Androgen therapy in the last six months before selection; 3. Active infections; 4. History of congestive heart failure stage III and IV NYHA; 5. History of major cardiovascular events like stroke, acute myocardial infarction, coronary or other arterial revascularization procedures in the last three months before selection; 6. Clinically relevant cardiac arrhythmia; 7. Clinically relevant abnormalities of functional hepatic tests; 8. Therapy with L-carnitine or its derivatives in the last three months before selection; 9. Pregnancy, lactating women or female subjects of childbearing potential who do not use an effective method of contraception; 10. Presence of relevant chronic medical conditions that could suggest exclusion of patient from the study or could interfere with assessment of study parameters, especially if the life expectation is less then one year; 11. Participation in another clinical study within the past month; 12. Known allergic reactions to L-carnitine or xylitol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess the safety and tolerability of the experimental solutions by: • recording the incidence and severity of adverse events; • recording a subjective questionnaire on the patient’s perception of well being; • monitoring the changes in routine blood biochemical and hematological parameters;Secondary Objective: 1. To assess the effects of experimental solutions • peritoneal clearances; • peritoneal transport characteristics with respect to Day 0 and the follow-up period 2. To assess the effects of experimental solutions on peritoneum functionality by evaluation of changes in CA 125 and protein levels in ultrafiltrate;Primary end point(s): recording the incidence and severity of adverse events; recording a subjective questionnaire on the patient’s perception of well being; monitoring the changes in routine blood biochemical and hematological parameters | — |
Countries
Italy
Outcome results
None listed